Biogen’s Alzheimer’s drug fight goes beyond the U.S. drugmaker’s unsuccessful attempt to get the European Medicines Agency to reconsider their view of Aduhelm, leading the company to withdraw its application Seek European Marketing Authorization.
Biogen said on Friday that European regulators said the data provided by the company was insufficient to support a positive review of the drug.This position remains largely unchanged from the EMA’s Committee for Medicinal Products for Human Use last December Recommend rejection Biogen’s application for the drug, which has the chemical name aducanumab. The committee noted that there was no link between amyloid reduction and patient improvement, as well as the drug-related risk of brain swelling and bleeding. The committee concluded that the agency’s opinion was that “the benefits of Aduhelm do not outweigh its risks, and it recommends denying marketing authorization.” Biogen has been seeking to re-examine that opinion.
“We thank the patients, caregivers and physicians who supported the re-examination process as part of the EMA review,” Priya Singhal, Biogen’s global head of safety and regulatory science and interim head of R&D, said in a prepared statement. The safety and efficacy of aducanumab, and we look forward to upcoming data readouts to continue to provide important information about the science of this new class of compounds.”
Aduhelm has not gained much market traction since its launch Accelerated FDA approval last June. As the first new Alzheimer’s drug approved in nearly 20 years, Aduhelm is expected to be a blockbuster. But Biogen’s financial statements show the drug’s 2021 sales of just $3 million. last year end, Biogen announces to slash Aduhelm’s $56,000-a-year price in half to boost sales.
The drug faced its biggest hurdle to commercialization earlier this month. Centers for Medicare and Medicaid Services says it will only offer Aduhelm to beneficiaries participating in clinical trials. The decision could affect broader drug reimbursement. Payers want CMS coverage to inform their reimbursement decisions.
in a statement Released after CMS coverage was established, Biogen called on the agency to reconsider its decision when more data on such drugs became available. Lecanemab, an anti-amyloid drug developed by Biogen’s partner Eisai. The Japanese pharmaceutical company issued its own statement saying it expects the design of its Phase 3 study to meet the evidence requirements set by the CMS. Eisai expects to report data from the clinical trial this fall.
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